Clinical trial Recruiting at 1 site Interventional Ages 30 to 65 Women only

HPV self-sampling in the ED to screen under-screened women

Official title: Developing and Implementing HPV SCREENED (Self-Collection REach and ENgagement in Emergency Departments) to Improve Cancer Equity

Run by Rutgers, The State University of New Jersey · NCT07657104 · Data updated 2026-11-12

This study tests whether giving an HPV self-sampling kit in the emergency department can help under-screened women get screened for cervical cancer and find those with HPV to guide follow-up care.

Quick facts

Study typeInterventional
Ages30 Years to 65 Years
SexWomen only
Enrollment100 (estimated)
SponsorRutgers, The State University of New Jersey
Academic / other
Locations2 sites (New Brunswick, New Jersey and 1 other locations)
StatusRecruiting
StartedOctober 15, 2026
Main results expectedJune 30, 2027
Study endsSeptember 30, 2027
Registry record updatedOctober 22, 2026
Trial IDNCT07657104 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Biological women aged 30-65 presenting to the ED who are overdue for cervical screening and meet language, mobility, and residency criteria in New Jersey.

Probably not a fit

Women who are pregnant, have a previous hysterectomy or cervical cancer, or are not overdue for screening may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot feasibility trial evaluates implementing HPV self-collection as a primary cervical cancer screening method for women aged 30-65 who are overdue for screening and present to the ED with non-critical illness. Participants receive education and an HPV self-sampling kit to complete in the ED, with immediate return of the specimen. Those who test positive for HPV are navigated to follow-up care at local clinics according to standard guidelines, aiming to reduce barriers to screening for women not regularly using primary care. The study hypothesizes that in-ED distribution and same-day kit return will reduce participant burden compared with mailed self-sampling approaches. The initiative is led by Rutgers with sites at two New Jersey hospitals and targets increasing access to cervical screening in under-screened populations.

Why it matters

Potential benefit: If successful, it could increase early detection of high-risk HPV and improve access to follow-up care for women who rarely use primary care.

How similar studies have gone: Previous mailed HPV self-sampling trials faced participation barriers; this study explores a light-touch, ED-based approach to see if it improves uptake.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* biological women,
* no prior hysterectomy or cervical cancer,
* not pregnant,
* last Pap \>3 years, last co-test \>5 years, or last HPV alone test \>5 years,
* speak English or Spanish,
* has a working cellphone,
* NJ residency
* ED patient

Exclusion Criteria:

* currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy);
* previous hysterectomy;
* previous diagnosis of cervical cancer;
* current menses

Where it's running

  • Robert Wood Johnson University Hospital
    New Brunswick, New Jersey, United States
    Recruiting
  • University Hospital
    Newark, New Jersey, United States
    Not yet recruiting

Study contacts

  • Principal investigator: Sara Heinert, PhD, MPH — Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School
  • Study coordinator: Sara Heinert, PhD, MPH
  • Email: sara.heinert@rutgers.edu
  • Phone: (732) 235-7872

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.